Bromocorn

Leaflet attached to the packaging: patient information

Bromocorn

2.5 mg, tablets

Bromocriptine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Bromocorn and what is it used for
• 2. Important information before taking Bromocorn
• 3. How to take Bromocorn
• 4. Possible side effects
• 5. How to store Bromocorn
• 6. Contents of the packaging and other information

1. What is Bromocorn and what is it used for

Bromocorn contains the active substance bromocriptine, which stimulates dopamine receptors D2 to release dopamine and increases dopamine levels in the hypothalamus, leading to inhibition of prolactin release. By increasing dopamine synthesis in the central nervous system, it improves its neurotransmitter functions. Additionally, it inhibits the release of somatotropin in the pituitary gland, which justifies its use in acromegaly. The effect of bromocriptine can be described as central (pituitary, hypothalamus) and peripheral (organs containing prolactin and dopamine D2 receptors).

Indications for use

• Parkinson's disease
• Acromegaly
• Prolactin-secreting pituitary tumors (prolactinoma)
• Hyperprolactinemia in men
• Suppression of lactation for medical reasons only, and if the doctor, after consulting with the patient, deems it necessary. Bromocriptine is not recommended for routine suppression of lactation. It should not be used to reduce symptoms of painful breast engorgement after childbirth, which can be successfully treated with other methods (e.g., breast support, cold compresses) and/or administration of ordinary painkillers.
• Disorders of the menstrual cycle, female infertility

This medicine is intended for patients over 15 years of age.

2. Important information before taking Bromocorn

When not to take Bromocorn

In postpartum women, there is a risk of certain symptoms. They occur very rarely and may include: hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders. For this reason, the doctor should monitor the patient's blood pressure, especially at the beginning of treatment. If the patient experiences hypertension, chest pain, or severe, persistent headache (with or without visual disturbances), they should contact their doctor immediately.

Warnings and precautions

Before starting treatment with Bromocorn, discuss it with your doctor.

• gastrointestinal bleeding or stomach ulcers,
• drowsiness and episodes of sudden sleepiness,
• shallow breathing or difficulty breathing,
• sharp chest pain,
• back pain, swelling of the lower limbs, or kidney function disorders,
• severe headache and/or transient visual disturbances (e.g., blurred vision) in postpartum women,
• unexpected nasal discharge in patients with prolactin-secreting pituitary tumors.

Particular caution is required if the patient has currently or has had in the past fibrotic (scar) reactions of the heart muscle, lungs, or abdominal cavity. In patients taking Bromocorn for a long time, the doctor will check if heart, lung, and kidney function is normal before starting treatment. An echocardiogram (heart ultrasound) will also be performed before starting treatment. During treatment, the doctor will pay particular attention to any signs potentially related to fibrotic reactions. If necessary, an echocardiogram will be performed. If a fibrotic reaction occurs, treatment will be discontinued.

If the patient or their relatives notice unusual behavior resulting from irresistible impulse, compulsion, or repetitive behavior, which may be harmful to the patient or others, they should inform their doctor. Such behavior is called impulse control disorders and may include addiction to gambling, compulsive or binge eating, excessive sexual drive, or intense sexual thoughts and feelings. The doctor may decide to adjust the treatment or discontinue the medicine.

Taking Bromocorn may restore fertility. Therefore, women of childbearing age who do not want to become pregnant should use effective contraception.

Particular caution is required in patients who have recently or are currently taking medications that affect blood pressure, such as vasoconstrictors (e.g., sympathomimetics or ergot alkaloids) together with ergometry and methylergometry. It is also not recommended to administer these medications with Bromocorn during the postpartum period.

Consult your doctor even if the above warnings refer to past situations.

Children and adolescents

The medicine is not intended for use in children and adolescents under 15 years of age and should not be used in this age group.

Bromocorn and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

It is recommended to exercise caution when administering strong inhibitors and/or substrates of the CYP3A4 enzyme (e.g., azole antifungals, HIV protease inhibitors).

It has been shown that concurrent use of macrolide antibiotics, such as erythromycin or josamycin, increases bromocriptine levels in the blood.

Concurrent administration of bromocriptine and octreotide in patients with acromegaly resulted in increased bromocriptine levels in the blood.

Since the therapeutic effect of Bromocorn is based on stimulation of central dopamine receptors, the effect of the medicine may be weakened by dopamine antagonists, such as antipsychotic medications (phenothiazines, butyrophenones, and thioxanthenes), as well as metoclopramide and domperidone.

Bromocorn with food, drink, and alcohol

Recommendations for taking the medicine with food can be found in section 3.

Do not drink alcohol while taking Bromocorn, as it may enhance the side effects of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. The doctor will decide whether to start, continue, or discontinue treatment, if there are any indications for it.

No increased frequency of miscarriages has been observed after discontinuation of Bromocorn. Numerous observations indicate that Bromocorn used during pregnancy does not negatively affect its course and outcome. Patients with pituitary tumors who become pregnant and discontinue Bromocorn treatment should be monitored throughout the pregnancy. In patients with symptoms of significant tumor growth, such as headaches or decreased vision, the doctor may consider resuming Bromocorn treatment or surgical treatment.

The medicine should not be used during breastfeeding, as it inhibits lactation.

Driving and using machines

Especially in the first days of treatment, hypotension may occur, leading to decreased concentration (episodes of sudden sleepiness or daytime sleepiness). Therefore, particular caution should be exercised when driving vehicles and operating machines.

Bromocorn contains lactose

One tablet contains 175.64 mg of lactose (which is equivalent to 184.88 mg of lactose monohydrate). If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Bromocorn contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Bromocorn

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.

Take the medicine with food.

Usually, the medicine is used as described below.

Adults

Parkinson's disease

To ensure optimal tolerance, treatment should start with a dose of 1.25 mg (half a tablet) per day, preferably in the evening, during the first week. The dose should be increased slowly to determine the minimum effective dose in each case. The dose should be increased gradually, by 1.25 mg per day, every week. The daily dose is divided into 2 to 3 doses.

The expected therapeutic effect can be achieved within 6 to 8 weeks. If this does not occur, the dose may be further increased by 2.5 mg per day, every week.

The usual range of doses used in monotherapy or combination therapy is 10 to 30 mg of bromocriptine per day.

If side effects occur during dose increase, the daily dose should be reduced and maintained at the reduced level for at least one week. After the side effects have subsided, the dose can be increased again.

In patients treated with levodopa, who experience movement disorders, it is recommended to reduce the levodopa dose before starting Bromocorn. After achieving a satisfactory response to Bromocorn, the levodopa dose can be further gradually reduced. In some patients, levodopa administration can be completely discontinued.

Acromegaly

Initially, 1.25 mg (half a tablet) 2 to 3 times a day, with gradual dose increase to 10-20 mg per day, depending on the clinical response and side effects.

Prolactinoma

1.25 mg (half a tablet) 2 to 3 times a day, with gradual dose increase to several tablets per day, to maintain adequate reduction of prolactin levels in the blood.

Hyperprolactinemia in men

1.25 mg (half a tablet) 2 to 3 times a day, with gradual dose increase to 5-10 mg per day.

Disorders of the menstrual cycle, female infertility

1.25 mg (half a tablet) 2 to 3 times a day. If the dose is ineffective, it should be gradually increased to 2.5 mg 2 to 3 times a day. Treatment should be continued until the menstrual cycle returns to normal and/or ovulation is restored. If necessary, treatment may be continued for several cycles to prevent the disease from recurring.

Suppression of lactation for medical reasons only, and if the doctor, after consulting with the patient, deems it necessary.

One tablet per day on the first day, one or two tablets per day on the second day, and one tablet twice a day from the third day for 14 days. Gradual initiation of treatment is not necessary in this indication.

Patients with kidney or liver function disorders

In patients with liver function disorders and/or kidney function disorders, the elimination rate of bromocriptine may be decreased, and the concentration of the medicine in the blood may increase. In such cases, the doctor will recommend reducing the dose of the medicine.

Elderly patients

Clinical experience, including reports of side effects collected after the marketing authorization of bromocriptine, does not indicate any differences in tolerance between elderly patients and younger patients. When choosing a dose for elderly patients, caution should be exercised. Due to the more frequent occurrence of decreased liver, kidney, or heart function in this group of patients, as well as the presence of other diseases or concurrent use of other medicines, treatment should be started with a lower dose.

If you feel that the effect of Bromocorn is too strong or too weak, consult your doctor.

Use in children and adolescents

Bromocorn should not be used in children and adolescents under 15 years of age.

Using a higher than recommended dose of Bromocorn

If you have taken more than the recommended dose of the medicine, contact your doctor immediately.

Symptoms of overdose: vomiting, nausea, dizziness, hypotension, orthostatic hypotension, tachycardia, hallucinations, lethargy, sleepiness.

In children who have accidentally taken bromocriptine, the following side effects have been reported: vomiting, sleepiness, and fever.

Missing a dose of Bromocorn

Do not take a double dose to make up for a missed dose.

Stopping treatment with Bromocorn

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bromocorn can cause side effects, although not everybody gets them.

Common side effects(occurring in 1 to 10 out of 100 patients): headache, sleepiness, dizziness, nasal congestion, nausea, constipation, vomiting.

Uncommon side effects(occurring in 1 to 10 out of 1,000 patients): disorientation, psychomotor agitation, hallucinations, involuntary movements, hypotension, orthostatic hypotension, orthostatic hypotension (which can very rarely cause fainting), dry mouth, allergic skin reactions, hair loss, leg cramps, fatigue.

Rare side effects(occurring in 1 to 10 out of 10,000 treated patients): psychotic disorders, insomnia, sleepiness, unusual sensations, visual disturbances, blurred vision, tinnitus, tachycardia, bradycardia, arrhythmias, pleural effusion, pleural fibrosis, pericarditis, pulmonary fibrosis, dyspnea, diarrhea, abdominal pain, retroperitoneal fibrosis, gastrointestinal bleeding, peripheral edema.

Very rare side effects(occurring in less than 1 out of 10,000 treated patients): increased libido, increased sexual activity, excessive daytime sleepiness, sudden sleepiness, reversible pallor of fingers and toes caused by cold (especially in patients with Raynaud's disease), a syndrome similar to malignant neuroleptic syndrome after sudden withdrawal of the product, heart valve disorders, and other related disorders, such as pericarditis or pericardial effusion.

One or more of the following early symptoms may occur: difficulty breathing, dyspnea, chest pain, or back pain, swollen legs. If any of these symptoms occur, contact your doctor immediately.

In addition, other side effects may occur due to impulse control disorders, which may include:

• strong impulse to gamble excessively, despite significant personal or family consequences,
• altered or increased sexual interests and behaviors of great importance to the patient or others, e.g., activities related to increased sexual drive,
• compulsive, uncontrolled spending or buying,
• episodic binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors, so you can discuss ways to control or limit these symptoms.

Rare cases of hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders have been reported during the use of bromocriptine to suppress lactation in the postpartum period.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C

02-222 Warsaw

tel.: 22 49 21 301

fax: 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bromocorn

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month stated.

Store in a temperature below 25°C.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Bromocorn contain

• The active substance of the medicine is bromocriptine mesylate. One tablet contains 2.5 mg of bromocriptine (which is equivalent to 2.87 mg of bromocriptine mesylate).
• The excipients are: potato starch, sodium croscarmellose, lactose monohydrate, magnesium stearate, talc.

What does Bromocorn look like and what does the packaging contain

Bromocorn is an oral tablet.

Packaging:

A cardboard box containing 1 tablet container made of orange glass with a shock-absorbing cap and a safety lock, containing 30 tablets.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

To obtain more detailed information about this medicine, contact the representative of the marketing authorization holder:

Pharmaceutical Cooperative Filofarm

ul. Pułaskiego 39, 85-619 Bydgoszcz

Tel.: (52) 342 67 88

Information for the blind and visually impaired: The content of the Bromocorn leaflet is available in the Ulotka Audio system under the nationwide free phone number 800 706 848.

Date of last revision of the leaflet